Pharma News

GaBI news digest for 14 October 2022

Home/Pharma News | Posted 14/10/2022

Selected news for the week of 14 October 2022 for GaBI readers.

FDA inspections in Iceland and Singapore for Alvotech and Strides

Home/Pharma News | Posted 14/10/2022

On 5 September 2022, Alvotech announced that it had received communication from the US Food and Drug Administration (FDA) that detailed the assessment of their Icelandic manufacturing facility and Alvotech’s subsequent written responses to FDA. This followed Strides announced the successful FDA inspection of their Singapore facility in early August 2022.

Novartis is set to spin-off Sandoz

Home/Pharma News | Posted 16/09/2022

Big pharma company Novartis announced on 25 August 2022 that it will spin off its generics and biosimilars arm, Sandoz.

New partnerships: Prestige-Intas and Samsung Bioepis-Samil

Home/Pharma News | Posted 02/09/2022

Prestige Biopharma (Prestige) and Intas Pharmaceuticals have entered a partnership to supply and commercialize Prestige Biopharma’s bevacizumab biosimilar in a number of countries globally. In addition, Samsung Bioepis has partnered with Samil to market their Lucentis (ranibizumab) biosimilar for ophthalmic diseases in South Korea.

Organon–Henlius partnership: biosimilars for women’s health

Home/Pharma News | Posted 24/06/2022

Organon, a global specialist in women’s health and expert in biosimilar commercialization, announced in mid-June 2022 that it had entered into an agreement with Shanghai Henlius Biotech, Inc. As part of this, Organon will license commercialization rights for biosimilar candidates referencing Perjeta (pertuzumab), and Prolia/Xgeva (denosumab) and will have global rights except for in China and its territories.

EMA authorizations: CRO generics suspended and Herceptin biosimilar refused

Home/Pharma News | Posted 17/06/2022

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has suspended the marketing authorizations of several generics medicines tested by Synchron Research Services on 20 May 2022. The committee also refused the marketing authorization for BioPharma’s Herceptin biosimilar, Tuznue, on 19 May 2022.

Lupin–Yabao partnership to bring paediatric medicines to China

Home/Pharma News | Posted 20/05/2022

In April 2022, global pharmaceutical company, Lupin announced that it has entered a strategic partnership with China’s Yabao Pharmaceutical Company. Together, the companies will work to meet the growing demand for quality drugs with paediatric formulations in Chinese markets.

Biosimilar Solutions to start trials of biosimilar filgrastim and GMP manufacturing

Home/Pharma News | Posted 16/05/2022

In late-March and mid-April 2022, Biosimilar Solutions Inc (Biosimilar Solutions) announced the start of its registrational clinical trials for BSC1020 and BSC0826 biosimilar filgrastim and on 14 March 2022, OcyonBio LLC (OcyonBio) announced a manufacturing and operations agreement to develop biosimilar drug product facilities for Biosimilar Solutions in Puerto Rico.

Aurobindo acquires Veritaz and Formycon–ATHOS partnership

Home/Pharma News | Posted 22/04/2022

In April 2022, Indian drugmaker, Aurobindo Pharma, acquired formulations business Veritaz. In addition, biosimilars specialist, Formycon, signed a partnership deal with ATHOS to merge development activities surrounding two biosimilars.

Fresenius Kabi acquire mAbxience and Ivenix

Home/Pharma News | Posted 15/04/2022

Fresenius Kabi is acquiring a majority stake in biosimilars company mAbxience, and is acquiring infusion pump maker, Ivenix outright. The deals are set to be completed by mid-2022.